Electronic Submission of User Manuals and Radiation Safety Reports for Electronic Products
This guidance clarifies that manufacturers can provide user manuals for electronic products in either paper or electronic form, recognizing the widespread use of electronic media while promoting reduced paper consumption, increased accessibility, and efficient content updates.
Recommended Actions
- Review current user manual distribution format and assess if electronic format would be beneficial
- If implementing electronic format:
- Ensure PDF format is used for documentation
- Establish process to provide hard copies when requested
- Verify English language requirement is met
- Set up system to deliver documentation directly to purchasers
- Update submission procedures for radiation safety reports to align with electronic documentation
- Implement process to track and respond to requests for hard copy versions
- Establish quality control process to ensure all electronic documentation is accessible and complete
- Create procedure to maintain both electronic and paper-based distribution capabilities
Key Considerations
Labelling
- User manuals can be provided in PDF format
- Documentation must be available in English language
- Electronic documentation can be provided via:
- Website download
- Compact disc (CD)
- Other common storage media (e.g., USB external drive)
- Hard copy must be provided at no additional cost if user cannot access electronic version
Safety
- Radiation safety reports can be submitted to FDA via:
- Email to RadHealthCustomerService@fda.hhs.gov in PDF format
- FDA’s eSubmitter software through Electronic Submissions Gateway
- CD using FDA’s eSubmitter software
- Hard copy paper documentation
Other considerations
- Information must be made available directly to the purchaser of the product
- If electronic versions of user manuals are submitted, the radiation safety report should also be submitted electronically
Relevant Guidances
- Including Manufacturer’s URL on Electronic Product Labels
- Device Labeling Requirements and Content for Premarket Approval Applications
- Labeling Requirements and Recommendations for Medical Devices
Related references and norms
- 21 CFR Part 1002.3: Performance data and technical data requirements for radiation emitting electronic products
- 21 CFR Parts 1020.20, 1020.30, 1020.40, 1030.10, 1040.10, 1040.20: Specific performance standards for various electronic products
Original guidance
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